Recalls / Class II
Class IID-0389-2026
Product
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
- Brand name
- Sodium Iodide I-131
- Generic name
- Sodium Iodide I-131
- Route
- Oral
- NDC
- 69208-000
- FDA application
- ANDA209166
- Affected lot / code info
- Batch I012626R-01, Exp 02/09/2026
Why it was recalled
Presence of Particulate Matter: Due to production issues
Recalling firm
- Firm
- Radnostix
- Manufacturer
- Radnostix, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4137 Commerce Cir, N/A, Idaho Falls, Idaho 83401-1205
Distribution
- Quantity
- 16 units
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2026-01-26
- FDA classified
- 2026-03-13
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0389-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.